Salarius Provides Update on Strategic Review Process and Plans to Support Ongoing Seclidemstat Clinical Trials by Further Reducing Expenses

Rhea-AI Summary

Salarius Pharmaceuticals, Inc. (SLRX) implements cost-saving measures to extend cash runway till the first half of 2025. The measures support additional data generation from ongoing clinical trials in hematologic cancers and Ewing sarcoma, showing promising response rates.

Financial Analyst

Salarius Pharmaceuticals' decision to implement cost-saving measures to extend their cash runway is a strategic move to ensure financial stability while continuing to fund critical clinical trials. The extension of the cash runway into the first half of 2025 indicates an effort to avoid dilutive financing in the near term, which could be favorable for current shareholders. By reducing operating expenses and cash compensation to non-employee directors, the company is showing a commitment to financial prudence. However, investors should monitor the company's burn rate and future funding requirements, as the success of the clinical trials will likely necessitate additional capital.

The transition of the CEO to a part-time consultant role could raise concerns about leadership continuity and strategic focus. While this move contributes to cost savings, stakeholders should evaluate the impact on the company's strategic direction and operational execution. The market will also likely scrutinize the forthcoming clinical data, as positive results could significantly enhance the company's valuation and attractiveness to potential strategic partners.

Medical Research Analyst

The reported 50% objective response rate (ORR) in the hematologic cancer trial and 60% ORR among first-relapse Ewing sarcoma patients present promising indicators of seclidemstat's therapeutic potential. These figures suggest that seclidemstat could be a significant player in the treatment landscape for these cancers, pending further validation in clinical trials. The ability to generate additional data without financial strain could be critical in demonstrating the drug's efficacy and safety profile to regulatory bodies and potential partners.

It is essential to understand that the ORR is a measure of the proportion of patients with a tumor size reduction of a predefined amount and for a minimum time period. However, long-term outcomes such as overall survival and quality of life improvements are crucial for the drug's approval and market success. As such, investors and stakeholders should look for these data points in the upcoming trial results to fully assess the drug's commercial potential.

Market Research Analyst

The strategic review led by Canaccord Genuity, LLC, aims to maximize shareholder value, which may include partnerships, mergers, or asset sales. The cost-saving measures could make Salarius more appealing to potential strategic partners by demonstrating fiscal responsibility and a longer runway to achieve milestones. The anticipated clinical data will be a critical factor in these strategic discussions.

Additionally, the biopharmaceutical sector is highly competitive and Salarius' ability to extend its cash runway while advancing clinical trials may provide a competitive edge. Investors should consider industry benchmarks for drug development costs and timelines when evaluating Salarius' progress. Moreover, the industry's response to the updated clinical data will be indicative of the market's belief in seclidemstat's potential and could influence Salarius' stock performance and partnership opportunities.

Company implementing a series of cost-savings measures designed to extend Salarius’ expected cash runway into the first half of 2025

Extended runway supports the generation of additional data from the ongoing Phase 1/2 clinical trials in hematologic cancers and Ewing sarcoma

HOUSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, today announced that its Board of Directors is implementing a series of additional cost-savings measures designed to extend Salarius’ expected cash runway into the first half of 2025. These measures will allow Salarius to support the generation of additional clinical data for seclidemstat in the ongoing MD Anderson Cancer Center (MDACC) investigator-initiated Phase 1/2 clinical trial in hematologic cancers and Salarius’ Phase 1/2 trial in Ewing sarcoma.

Earlier this year Salarius announced that MDACC had resumed enrollment in the hematologic cancer trial, and based on the available data Salarius is encouraged by the 50% objective response rate (ORR) previously reported by MDACC researchers. Salarius also reported earlier this year that an additional Ewing sarcoma patient treated with a combination of seclidemstat, topotecan and cyclophosphamide (TC) achieved a partial response, increasing the ORR among first-relapse Ewing sarcoma patients to 60%.

In connection with the cost-savings measures, David Arthur, the Company’s President and Chief Executive Officer, has ended his full-time employment and transitioned to a part-time consultant role, effective February 20, 2024. He will continue to serve as Chief Executive Officer and support Salarius’ ongoing activities. The cost-savings measures also include reducing operating expenses and reducing the cash compensation payable to the Company’s non-employee directors beginning in the second quarter of 2024.

In August 2023 Salarius announced that it had retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value. While these efforts are ongoing, the Company continues to support its clinical programs, as appropriate, and the cost-savings measures approved by the Board of Directors are designed to enable the Company to continue supporting such activities.

“With these additional expense reductions, we are able to extend our cash runway to allow for the generation of additional clinical data in both seclidemstat clinical trials. The Board of Directors believes this decision is in the best interest of shareholders, and the additional data may enhance our opportunities to maximize shareholder value,” said Dr. William McVicar, Chair of the Board. “By further reducing expenses, we are able to support the ongoing clinical development of seclidemstat into the first half of 2025. We look forward to reviewing the updated clinical data from both trials later this year and to sharing those data with prospective strategic partners and other interested parties.”

About Seclidemstat
Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the FDA. In addition to the MDACC investigator-initiated trial, seclidemstat has been studied in a company-sponsored Phase 1/2 trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma.

Researchers at MDACC previously reported interim clinical trial results evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who relapsed or progressed after hypomethylating agent therapy. Of eight evaluable patients, four (50%) had an objective response. These researchers reported a 90% probability of survival for 11 months in patients receiving seclidemstat plus azacitidine. Typically, overall survival is four to six months after failing therapy with hypomethylating agents. The hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center is now listed as active and recruiting on clinical trials.gov – trial NCT04734990.

The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide as a treatment for relapsed and refractory Ewing sarcoma. To date, a total of 13 relapsed Ewing sarcoma patients, including five patients with first relapse and eight patients with second relapse, have been enrolled at seclidemstat doses of 600 mg or 900 mg twice daily in combination with TC.

• The five first-relapse patients demonstrated a 60% ORR and a 60% disease control rate (DCR) including one complete response and two partial responses. Among the three patients achieving OR, the median progression-free survival (mPFS) has not been reached with these patients still alive and have disease control and objectives responses at 17.4, 25.7 and 27.2 months, and increasing, after starting seclidemstat + TC combination treatment.
• The eight second-relapse patients demonstrated a 13% ORR, a 25% DCR and a mPFS of 1.6 months (range: 0.0 months to 10.7 months).
• Together the 13 first- and second-relapse patients demonstrated a mPFS of 8.1 months (range: 2.0 months to 27.2 months). Five patients, or 38%, achieved confirmed disease control and progression has not been observed in any of these patients while on study.
  
  

Salarius has completed FDA Type B End of Phase 2 (EOP2) meeting process for the Seclidemstat Ewing sarcoma development program and has amended the current clinical trial protocol to reflect guidance agreed to with FDA. There is currently one patient enrolled in the Ewing sarcoma clinical trial, who recently achieved a partial response defined by a 30% or greater reduction in their target lesions, and this patient is continuing treatment with seclidemstat plus TC therapy. The Ewing sarcoma trial is currently active but is not currently enrolling additional patients.

About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, Salarius’ lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader being developed for the treatment of non-Hodgkin’s lymphoma. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “encouraging,” “might,” “should,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: Salarius’ expectations regarding the exploration of strategic alternatives, opportunities to extend Salarius’ resources, the Company’s expected cash runway, the Company’s expectations that the cost-savings measures will support the generation of additional data from the ongoing Phase 1/2 clinical trials in hematologic cancers and Ewing sarcoma; the future of the Company’s operations and product candidates; the future of the Company’s preclinical studies and clinical trials and development activities; the advantages of protein degraders including the value of SP-3164 as a cancer treatment; the value of seclidemstat as a treatment for Ewing sarcoma, Ewing-related sarcomas, and other cancers and its ability to improve the life of patients. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in these forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the risk that exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; the potential for the Company to seek other alternatives for restructuring and resolving its liabilities, including bankruptcy proceedings, a dissolution and orderly wind-down of operations; expectations regarding future costs and expenses; our product candidates being in early stages of development; the uncertainty about the paths of our programs and our ability to evaluate and identify a path forward for those programs, particularly given the constraints we have as a small company with limited financial, personnel and other operating resources (including with respect to the allocation of our limited capital and the sufficiency of our capital in the near term for any path we do select); Salarius’ ability to continue as a going concern; the sufficiency of Salarius’ capital resources; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed successfully and on attractive terms or at all; whether our cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital requirements; changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis; the risks associated with reductions in workforce, including reduced morale and attrition of additional employees necessary for the strategic reprioritization; the risk of not having a full-time chief executive officer; future clinical trial results and the impact of such results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the competitive landscape and other industry-related risks; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

Contact:

LHA Investor Relations
Kim Sutton Golodetz
kgolodetz@lhai.com
212-838-3777

What cost-saving measures has Salarius Pharmaceuticals (SLRX) implemented?

Salarius Pharmaceuticals has implemented cost-saving measures to extend its expected cash runway into the first half of 2025.

What clinical trials are ongoing for Salarius Pharmaceuticals (SLRX) in hematologic cancers and Ewing sarcoma?

Salarius Pharmaceuticals is conducting Phase 1/2 clinical trials in hematologic cancers and Ewing sarcoma to generate additional clinical data for seclidemstat.

What is the objective response rate (ORR) reported by MD Anderson Cancer Center (MDACC) for hematologic cancers in the trial?

MD Anderson Cancer Center researchers reported a 50% objective response rate (ORR) for hematologic cancers in the ongoing clinical trial.

What is the ORR among first-relapse Ewing sarcoma patients treated with seclidemstat, topotecan, and cyclophosphamide (TC)?

The objective response rate (ORR) among first-relapse Ewing sarcoma patients treated with the combination was reported to be 60%.

Who has transitioned to a part-time consultant role in Salarius Pharmaceuticals (SLRX)?

David Arthur, the President and Chief Executive Officer, has transitioned to a part-time consultant role in Salarius Pharmaceuticals.

Which financial firm was retained by Salarius Pharmaceuticals (SLRX) for a strategic review of alternatives in August 2023?

Salarius Pharmaceuticals retained Canaccord Genuity, LLC for a strategic review of alternatives in August 2023.